NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

Excellent research Lykiri, thank you. This announcement is extremely positive. Through this acquisition, not only was Northwest able to buy the necessary technology to close and automate production, (and throw up some roadblocks to potential competition) they were able to find some very knowledgeable and talented personnel.

I did some research on Flaskworks and their MicroDEN system last year. It was born from a grant from the NIH and part of the Small Business Innovation Research Project:

NIH/NCI 397 - Manufacturing Innovation for the Production of Cell- Based Cancer Immunotherapies

https://sbir.cancer.gov/funding/contracts/397

Fast track proposals will be accepted.
Direct-to-Phase II proposals will not be accepted.
Number of anticipated awards: 2-4
Budget (total costs, per award):
Phase I: up to $400,000 for up to 9 months
Phase II: up to $2,000,000 for up to 2 years
PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.
 
Summary
Cancer immunotherapy is a therapeutic approach that directs a patient’s own immune system to eradicate their tumor cells. Past and current NCI investments in adoptive T cells, CAR-T cells, NK cells, and other cell-based cancer immunotherapies have resulted in the translation of many lab-specific approaches into early clinical trials. Importantly, reproducible and robust production methods are critical to ensure that advances in basic research result in successful translation of cell-based therapies. Clinical development of such therapies requires multi-center, randomized clinical trials that must be supported with high quality, consistent, and reproducible cell-based products. Patient-specific autologous or allogeneic lots must be adequately characterized to ensure that similar products are given to all patients. For non-patient specific cell-based therapies, large-scale and reproducible manufacturing technologies are needed to produce high-quality products with uniform identity and potency. Current limitations in cell manufacturing can increase both the cost and time required to bring a therapy to market and can result in missed opportunities to evaluate promising new cell-based therapies. Product failures can be attributed to poor product design and characterization, as well as inadequate scale-up and manufacturing processes; therefore, further investments are needed to develop state-of-the art manufacturing technologies and processes to advance cell-based cancer immunotherapies at the commercial-scale. Effective use of science and engineering principles during the early development phase of a cell-based therapy can improve both the efficiency and reliability of the manufacturing process and the quality of the final product. Moreover, it is anticipated that standardized approaches to manufacturing, process analytics, release testing, and product characterization will result in more rapid, cost-effective product development and a higher level of regulatory success. Achieving the desired level of standardization for current and future cell-based cancer immunotherapy products will require both pragmatic research to establish consistent manufacturing processes, as well as the development of new innovations and technologies.
 
Project Goals
The overall goal of this contract topic is to facilitate the development of innovative methods and technologies capable of improving and modernizing product manufacturing processes for cell-based cancer immunotherapies. This includes the use of autologous, allogeneic, or pluripotent cells. Offerors submitting proposals under this solicitation are strongly encouraged to establish collaborative relationships with clinical product development companies focused on the development of specific cell-based products. In all cases, it is expected that offerors will demonstrate the utility of their innovation(s) in the context of at least one cell-based product, which is representative of a particular class of cell-based cancer immunotherapies.
Examples of manufacturing innovations/advancements might include, but are not limited to:
* Automated closed systems for cell separation, genetic modification, differentiation, and/or expansion;
* Low-cost, high-efficiency methods for genetic modification to support cell engineering;
* Standardized assays and/or surrogates to evaluate cell attributes that ensure lot-to-lot consistency in terms of phenotype, functionality, quality, and potency;
* Real-time, non-destructive test methods with sensors and/or imaging technologies to assess critical quality attributes (e.g., contamination); and/or
* Process analytics capable of feedback control in response to real-time changes in critical attributes of the cell product.
 
It is expected that Phase I proposals will focus on novel inventions related to innovations or improvements in cell manufacturing processes, including in-line or on-line (i.e., continuous) process analytics to support product consistency and safety, as well as GMP production of a particular class of cell therapies. Phase II proposals should demonstrate the scalability and validation of the production platform or process improvements developed in Phase I. Engineering and process solutions must be capable of regulatory compliance with FDA Guidelines. The long-term goal of this initiative is to provide the tools necessary for efficient, high-quality manufacturing of novel products in the emerging field of cell-based cancer immunotherapies.
 
Phase I Activities and Deliverables
* Develop a device/technology/process to support commercially-relevant manufacturing advancements or improvements for the production of a specific class of cell-based cancer immunotherapies (e.g., CAR-T cells, adoptive T-cells, NK cells)
* Establish defined specifications, assays and/or metrics to interpret scientific data supporting the feasibility of the device/technology/process, with respect to reproducible product manufacturing, process analytics, and/or process controls
* Demonstrate the suitability of the device/technology/process to improve relevant manufacturing metrics (e.g., product uniformity, quality, efficiency, cost-effectiveness) for at least one cell-based product, which is representative of a particular class of cell-based cancer immunotherapies
* Provide proof of collaboration or partnership with an entity that is developing a representative cell-based therapeutic agent OR otherwise demonstrate access to a representative cell-based therapeutic agent through other means (e.g., internal drug development program), that can be used for validation of the device/technology/process
* Demonstrate pilot-scale beta-testing of the production process to demonstrate reproducible performance within appropriate specifications for identity, purity, potency, and/or other relevant metric for the chosen cell-based immunotherapy product
 
Phase II Activities and Deliverables
* Generate scientific data demonstrating the proposed scalability (e.g. scale-up, scale-out, point-of-use) of the production platform, process analytics and/or process controls
* Develop an at-scale prototype of the device/technology/process with detailed specifications for hardware/software that supports the production platform or process analytics/process controls improvements
* Validate the production innovation and/or process improvements, including standards for calibrating any novel process analytics or process controls that monitor production
 
Receipt date: October 23, 2019, 5:00 p.m. Eastern Daylight Time
Apply for this topic on the Contract Proposal Submission (eCPS) website.
For full PHS2020-1 Contract Solicitation, CLICK HERE. 
 
Posted Date: 
July 10, 2019


SBIR Phase I: Automated Closed Systems for Manufacturing Autologous Dendritic Cell Therapies

https://www.sbir.gov/sbirsearch/detail/1521705

Award Information
Agency:
National Science Foundation
Branch:
N/A
Contract:
1819306
Agency Tracking Number:
1819306
Amount:
$225,000.00
Phase:
Phase I
Program:
SBIR
Solicitation Topic Code:
BT
Solicitation Number:
N/A
Timeline
Solicitation Year:
2017
Award Year:
2018
Award Start Date (Proposal Award Date):
2018-07-01
Award End Date (Contract End Date):
2018-12-31
Small Business Information
FLASKWORKS, LLC
165 Waltham Street, Newton, MA, 02465
DUNS:
080172813
HUBZone Owned:
N
Woman Owned:
N
Socially and Economically Disadvantaged:
N
Principal Investigator
Name: Jennifer Rossi
Phone: () -
Email: [e-mail]
Business Contact
Name: Jennifer Rossi
Phone: [phone]
Email: [e-mail]
Research Institution
N/A
Abstract
The broader impact/commercial potential of this Small Business Innovation Research (SBIR) project is in the development of new technologies to manufacture personalized therapies for cancer and other diseases that are based on a patient's own cells. Such therapies have shown remarkable success in recent years, however, manufacturing these therapies is challenging because mass production techniques cannot be employed when each patient receives a unique therapy. Indeed, for therapies based on dendritic cells, which are an important part of the human immune system, there are no manufacturing systems currently available that can perform all of the required steps. This project will address this major unmet need by leveraging advanced concepts in engineering and biology to design an integrated system for cost-effective manufacturing of dendritic cell therapies. Given the large number of personalized cell-based therapies currently in clinical trials, and recently approved therapies, such a system is expected to address a major societal need and have significant commercial potential. This SBIR Phase I project proposes to develop a manufacturing system to cover the steps involved in the manufacturing of autologous dendritic cell therapies. Because of the low abundance of these cells in blood, dendritic cells are typically generated from blood-derived monocytes. Following differentiation of monocytes into dendritic cells, these cells are then matured and stimulated with tumor-specific antigens. These steps represent discrete unit operations that require a system capable of handling both adherent and non-adherent cell types, different reagents for each step, and the ability to transition from one step to another with minimal loss of cells. Further, all steps must be performed in a disposable single-use enclosure. In order to achieve automation and integration of these steps, the proposed system will leverage innovations in perfusion-based dendritic cell culture and novel and cost-effective bioreactor design strategies. A combination of computational modeling and rapid-prototyping techniques will be employed for rapid iteration of prototypes and testing with potential users involved in therapeutic development. Successful completion of this project will result in feasibility demonstration of an integrated manufacturing system developed with significant end user feedback. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.




SBIR Phase II: Automated Closed Systems for Manufacturing Autologous Dendritic Cell Therapies

https://www.sbir.gov/sbirsearch/detail/1644527

Award Information
Agency:
National Science Foundation
Branch:
N/A
Contract:
1926967
Agency Tracking Number:
1926967
Amount:
$749,998.00
Phase:
Phase II
Program:
SBIR
Solicitation Topic Code:
BT
Solicitation Number:
N/A
Timeline
Solicitation Year:
2017
Award Year:
2019
Award Start Date (Proposal Award Date):
2019-09-01
Award End Date (Contract End Date):
2021-08-31
Small Business Information
FLASKWORKS, LLC
38 Wareham Street, 3rd Floor, Boston, MA, 02118
DUNS:
080172813
HUBZone Owned:
N
Woman Owned:
N
Socially and Economically Disadvantaged:
N
Principal Investigator
Name: Jennifer Rossi
Phone: [phone]
Email: [e-mail]
Business Contact
Name: Jennifer Rossi
Phone: [phone]
Email: [e-mail]
Research Institution
N/A
Abstract
The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is in the development of new technologies to manufacture personalized therapies for cancer and other diseases, based on a patient's own cells. Such therapies have shown tremendous potential in the treatment of previously intractable cancers. However, challenges in manufacturing these completely personalized therapies are a significant impediment to the ability to realize their full societal potential both in terms of therapeutic efficacy and cost. This project aims to remove major manufacturing barriers for therapies based on dendritic cells, which are an important part of the human immune system and can be modified to target specific diseases. No manufacturing systems currently available can perform all the required steps of manufacturing personalized dendritic cell therapies. This project will address this major unmet need by leveraging advanced concepts in engineering and biology to design an integrated system for cost-effective dendritic cell therapy manufacturing. Given the large number of personalized cell-based therapies currently in clinical trials and recently approved, such a system is expected to address a major societal need and have significant commercial potential. This SBIR Phase II project will advance to commercialization an advanced bioreactor system for closed-system manufacturing of autologous dendritic cell therapies. Multiple technological challenges must be overcome to automate and integrate the unit operations associated with the manufacturing of these therapies. Because of their low abundance in blood and tissue, dendritic cells are typically generated from leukapheresis-derived monocytes. Adherent monocytes must first be converted into nonadherent immature dendritic cells via incubation inIL4 and GM-CSF, prior to maturation and stimulation with tumor specific antigens. In order to achieve automation and integration of these steps on a single platform, the proposed system will build on successful Phase I work in perfusion-based dendritic cell culture that enables reduction of process steps associated with cytokine infusion and achievement of perfusion in a simple and cost-effective single-use bioreactor design. In addition, an agile product development methodology will be utilized in conjunction with computational modeling to rapidly and iteratively create prototypes and test them in the hands of potential customers. Feedback obtained from these users will be incorporated into the assembly of a pre-production beta system to be launched commercially at the end of Phase II. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.